[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-associated-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-associated-lymphoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100636233","early-phase-1-exploratory-study-on-the-treatment-of-eb-virus-positive-hiv-associated-lymphoma-with-ebv-mrna-vaccine-100636233",false,"NCT07563023","Exploratory Study on the Treatment of EB Virus Positive HIV Associated Lymphoma With EBV mRNA Vaccine","Inclusion Criteria:\n\n* 1\\. Male or female patients aged ≥ 18 years during screening.\n* 2\\. Histological or cytological diagnosis of HIV associated lymphoma, including but not limited to diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Hodgkin lymphoma (HL), etc.:\n\n  1. Initial treatment population: patients who have not received systematic anti-tumor treatment;\n  2. Relapse resistant population: patients who have received at least first-line treatment in the past and have experienced treatment failure or intolerance; Relapse is defined as the appearance of new lesions at the primary site or other locations after achieving complete remission (CR); Difficult to treat is defined as any of the following situations: (1) failure to achieve PR after ≥ 2 treatment cycles; (2) failure to achieve CR after ≥ 4 treatment cycles; (3) failure to achieve complete remission after autologous hematopoietic stem cell transplantation; (4) If the best therapeutic effect or end cause is PD, the number of cycles is not required (the same definition applies to relapsed\u002Frefractory lymphoma in the following text).\n* 3\\. Positive for EB virus infection (tissue EBER ISH\u002FFISH testing).\n* 4\\. Complete at least 2 cycles of systemic chemotherapy without achieving CR (the initial treatment population must complete the entire chemotherapy course of the first-line treatment plan, unless intolerant).\n* 5\\. ECOG physical condition score: 0-2 points.\n* 6\\. Expected survival period ≥ 3 months.\n* 7\\. The main organ functions well, and the relevant examination indicators meet the following requirements:\n* 8\\. The subject has no pregnancy plan during the treatment period and agrees to voluntarily take effective contraceptive measures during the trial period and within 4 months of stopping treatment, and the pregnancy of women of childbearing age is negative.\n* 9\\. Able to understand and voluntarily sign a written informed consent form before the experiment.\n* 10\\. Able to communicate well with researchers and willing to follow the protocol to complete the experiment.\n\nExclusion Criteria:\n\n* 1\\. The patient has a history of other tumors, except for the cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma and other malignant tumors that the researchers think can be included.\n* 2\\. Known to have aggressive NK cell leukemia or concomitant hemophagocytic syndrome.\n* 3\\. Known to have uncontrolled cardiac clinical symptoms or diseases, such as New York Heart Association (NYHA) grade II or above heart failure, unstable angina, myocardial infarction within 6 months, clinically significant and requiring treatment or intervention in patients with supraventricular or ventricular arrhythmias.\n* 4\\. Any active autoimmune disease or autoimmune disease history, including but not limited to immune related neurological disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease, including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens Johnson syndrome (except for type I diabetes mellitus using a stable dose of insulin).\n* 5\\. If there are any uncontrollable clinical diseases (such as respiratory, circulatory, digestive, nervous, hematological, urogenital, endocrine system diseases) or mental illnesses (such as depression, schizophrenia) or other major diseases that, according to the researcher's assessment, may hinder the provision of informed consent, interfere with the interpretation of the trial results, pose risks to the subjects participating in this trial, or otherwise affect the achievement of the trial objectives.\n* 6\\. Patients with a known history of interstitial pneumonia or highly suspected of having interstitial pneumonia; Patients with lung abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial period.\n* 7\\. Allergic to the experimental drug (including any excipients). Previous history of severe allergies to any medication, food, or vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.\n* 8\\. Patients who have had less than 4 weeks or 5 half lives (whichever is shorter) since their last anti-tumor treatment, or whose anti-tumor treatment-related adverse reactions (excluding hair loss) have not recovered to NCI CTCAE ≤ 1 or baseline standards after previous anti-tumor treatments.\n* 9\\. Subjects who receive systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 14 days or 5 half lives (whichever is shorter) prior to the first administration. In the absence of active autoimmune diseases, inhalation or topical use of steroids and adrenal hormone replacement with a dose ≤ 10 mg\u002Fday of prednisone therapeutic dose is allowed.\n* 10\\. Within 3 months prior to the first administration, have received mRNA vaccines or similar nanoparticles such as LNP for drug delivery.\n* 11\\. Previously received organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* 12\\. Blood donation or significant blood loss (\\>450 mL) within the first 3 months of screening.\n* 13\\. Those who have undergone major surgery within the 4 weeks prior to screening (excluding minor surgeries such as catheter placement or biopsy surgery as required by the protocol), or whose impact of surgery or trauma has been eliminated for less than 14 days prior to enrollment.\n* 14\\. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcohol or drug abuse.\n* 15\\. Known hepatitis B B virus, hepatitis C virus, and syphilis infection, or hepatitis B B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), and treponema pallidum (TP) antibody were positive when screening: HBsAg (+) or HBcAb (+), and HBV DNA copy number ≥ 2000 IU\u002FmL (or the lower limit of positive detection value in the research center); HCVAb positive and HCV RNA ≥ ULN of the research center.\n* 16\\. The patient has a history of active pulmonary tuberculosis (TB) or active TB; Or severe acute or chronic infections that require systemic treatment.\n* 17\\. Pregnant or lactating women.\n* 18\\. The researchers believe that there are any other factors that are not suitable for the subjects to enter this trial.","ALL","18 Years",{"count":18,"type":19},6,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","HIV related lymphoma is characterized by high pathological malignancy, late disease course, poor bone marrow reserves, immune deficiency, and high risk of infection. It is still one of the main causes of death in AIDS patients. EB virus is believed to be involved in the pathogenesis of approximately half of HIV related NHL and almost all HIV related HL; EBV can be found in almost all patients with primary HIV associated central nervous cell lymphoma (PCNSL). With the widespread application of antiretroviral (ART), the incidence rate of NHL has decreased by about 50% due to the reduction of PCNSL and DLBCL immunoblastic subtypes. However, the burden of HIV related BL and HL has increased.\n\nThe immune efficacy targeting EBV may provide a new treatment option for EBV positive HIV associated lymphoma. The EBV mRNA vaccine in this study has shown potential anti-tumor efficacy in lymphoma. Considering the close relationship between EBV and the occurrence and development of HIV associated lymphoma, and the lack of standard first-line and second-line treatment options for this population, we plan to continue exploring the application of this product in more types of lymphoma based on previous research.",[25],"HIV Associated Lymphoma","NOT_YET_RECRUITING","2026-04-28",{"date":29,"type":30},"2026-05-01","ACTUAL",{"date":29,"type":19},{"date":33,"type":19},"2028-12-31",{"name":35,"class":36},"West China Hospital","OTHER",{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":20,"phases":47,"briefSummary":50,"conditions":51,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100542472","phase-1-t-cell-therapy-eb103-in-adults-with-relapsedrefractory-b-cell-non-hodgkins-lymphoma-nhl-100542472","NCT06343311","T-Cell Therapy (EB103) in Adults With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (NHL)","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed\u002FRefractory (R\u002FR) B-Cell Non-Hodgkin's Lymphoma (NHL)","STARLIGHT-1","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent\n* Histologically confirmed R\u002FR B-cell non-Hodgkin's lymphoma (NHL)\n* Adequate organ function\n* Relapsed or refractory (R\u002FR) disease defined as ONE OR MORE of the following:\n\n  * R\u002FR after ≥ 2 lines of systemic therapy\n\n    * For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R\u002FR after ≥ 1 lines of systemic therapy\n  * Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)\n  * For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens\n* All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:\n\n  * Anti-CD20 monoclonal antibody AND\n  * An anthracycline-containing chemotherapy regimen\n* Positron emission tomography (PET)-positive disease according to Cheson 2014\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Toxicities due to prior therapy must be stable and recovered to Grade 1 or less\n\nExclusion Criteria:\n\n* Prior CD19-targeted cellular therapy\n* History of Richter's transformation of chronic lymphocytic leukemia (CLL)\n* History of another primary malignancy that has not been in remission for ≥ 2 years.\n* History or presence of clinically relevant Central Nervous System (CNS) pathology\n* CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms\n* Subjects with active cardiac lymphoma involvement which is not responding to treatment\n* History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years\n* History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents\n* Venous thrombosis or embolism not managed on a stable regimen of anticoagulation\n* Autologous HSCT within 3 months of informed consent\n* Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening\n* Live vaccine within 3 months prior to planned start of conditioning regimen",{"count":46,"type":19},21,[48,49],"PHASE1","PHASE2","This is an open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed\u002Frefractory (R\u002FR) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.",[52,53,54,55,56,57,58,59,60,61,62,25,63,64,65],"B-Cell Non-Hodgkin's Lymphoma (NHL)","Lymphoma, Non-Hodgkins","Lymphomas Non-Hodgkin's B-Cell","Non-Hodgkin Lymphoma","Non-Hodgkin's Lymphoma","Large B-Cell Lymphoma","Lymphoma, Non-Hodgkin's, Adult","Lymphoma","Refractory Non-Hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","Lymphoma, Non-Hodgkin","CNS Lymphoma","High-grade B-cell Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[67,56,68,59,57,60,61,69,63,64,65],"B-Cell Non-Hodgkin's Lymphoma","NHL","HIV Lymphoma","RECRUITING","2025-08-04",{"date":73,"type":30},"2025-08-07",{"date":75,"type":30},"2024-06-01",{"date":77,"type":19},"2027-12-31",{"name":79,"class":80},"Estrella Biopharma, Inc.","INDUSTRY"]